First Ever Generic Version of Effexor XR FDA-Approved

The FDA has approved the first ever generic version of Effexor XR (venlafaxine hydrochloride) to treat major depressive disorder.

Teva Pharmaceuticals is expected to begin shipping the generic this week. It will be available as extended-release capsules in 37.5 mg, 75 mg and 150 mg strengths. Teva was also granted exclusive marketing rights for the generic for a period of 180 days.

“The approval of this widely used antidepressant is another example of the FDA’s efforts to increase access to safe and effective generic drugs,” said Keith Webber, Ph.D., deputy director of the FDA Office of Pharmaceutical Science in the FDA news release. “Access to treatments for depression is important because depression can interfere with a person’s daily life and routine, which can significantly affect relationships with family and friends.”

According to the National Institute of Mental Health, major depressive disorder is the most common form of depression in the United States, affecting about 14.8 American adults in 2005. It is the leading cause of disability for Americans ages 15 to 44. A 2004 CDC study found that antidepressants are the most commonly prescribed drugs in the U.S.

Effexor is manufactured by Wyeth Pharmaceuticals, which merged with Pfizer last year. According to a press release from Teva, Effexor generated about $2.75 billion in sales in the U.S. last year.